Status:
COMPLETED
The Effect of Prolonged Pramlintide Infusion in Pediatric Diabetes
Lead Sponsor:
Baylor College of Medicine
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
12-21 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to see if reducing the dose of insulin before a meal and giving both pramlintide and insulin as dual wave infusions will lower the chance of low blood sugars after a meal....
Detailed Description
The Diabetes Control and Complications Trial (DCCT) showed that improving blood sugar control for individuals with Type 1 diabetes (T1DM) stopped or delayed the onset of long-term complications. As a ...
Eligibility Criteria
Inclusion
- Twenty (20) children with T1DM will be recruited for these studies. These children will be subjects of the Texas Children's Hospital Diabetes Care Center. The subjects must be:
- Between 12-21 years of age at the time of enrollment.
- Have been diagnosed with diabetes for at least 2 years and in good control (HbA1C less than 8.5%).
- Be on continuous subcutaneous insulin infusion using an insulin pump.
- Subjects must be otherwise healthy except for their T1DM and treated hypothyroidism.
- Menstruating women must have a negative pregnancy test.
- Hemoglobin equal to or \> 12 g/dL before each study.
- Weight more than 44 kg. -
Exclusion
- Age greater than 22 years or less than 12 years at the time of study
- Any chronic disease: leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc or on treatment that might directly or indirectly affect glucose homeostasis, except for diabetes and hypothyroidism stable on medications
- Anemia (hemoglobin less than 12mg/dl)
- Lack of a supportive family environment
- Positive pregnancy test in menstruating young women
- Evidence or history of chemical abuse
- Hgb A1C greater than or equal to 8.5 % in a diabetic subject
- BMI \> 90 % tile for age or \< 10 % tile for age
- Weight less than 44 kg. -
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00206297
Start Date
October 1 2003
End Date
February 1 2006
Last Update
July 14 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor College of Medicine
Houston, Texas, United States, 77030